Regulatory Affairs Manager

Regulatory Affairs Manager

work outline icon0 - 5 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Zeon Biotech Pvt. Ltd.

time outline iconAhmedabad, Gujarat, India

Posted on 27-05-2025

1 Vacancy

Description

  • Develop and implement regulatory strategies for new product development and market expansion.
  • Review and approve labeling, artwork, packaging, and promotional materials for regulatory compliance.
  • Liaise with regulatory authorities and manage communications, including handling queries, deficiencies, and audits.
  • Ensure compliance with global regulatory requirements across product lifecycles.
  • Collaborate with R&D, QA/QC, manufacturing, and marketing teams for timely submission of accurate documentation.
  • Monitor regulatory changes and update internal policies, SOPs, and teams accordingly.
  • Guide and mentor the regulatory affairs team; manage performance and training needs.
  • Maintain regulatory intelligence and databases; ensure timely updates and documentation.

 

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Key Skills

Attention to DetailCommunicationPositive AttitudeTeam Work

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